India's Zydus Cadila seeks DCGI nod to undertake human trial for COVID-19 monoclonal antibodies cocktail
India's Zydus Cadila has sought regulatory approval for clinical trials of its antibody cocktail to treat mild Covid-19.
Zydus has announced a biological therapy ZRC-3308, used to treat mild Covid-19. The pharmaceutical company now seeks DCGI (Drugs Controller General of India) nod to undertake clinical trials for monoclonal antibodies cocktail that can neutralise Covid infection.
The treatment candidate, ZRC-3308, was earlier shown to reduce lung damage during animal trials, the drugmaker said, adding it was found to be safe and well-tolerated.
The therapy is a cocktail of two monoclonal antibodies, which mimic natural antibodies that the body generates to fight infection.
''Zydus Cadila today announced that its biological therapy ZRC-3308, a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild Covid 19. SARS-CoV-2 spike protein targeted, neutralizing monoclonal antibody based treatments have received emergency use authorization in mild COVID 19 in the US, Europe and in India because they significantly reduced viral load in mild patients and their rate of hospitalization,'' Cadila Healthcare said in an exchange filing.
Zydus is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of Covid-19, it said. Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI.
ZRC-3308 is a cocktail of two monoclonal antibodies targeting two unique epitopes on the spike protein of SARSCoV-2. The monoclonal antibodies of ZRC-3308 have been specifically designed to provide protection for a much longer period of time than the currently approved products. The enhanced design would also help in preventing any further tissue damage and thereby reducing the risk of severe disease, the company added.
The US Food and Drug Administration has given emergency use authorisations to similar treatments developed by Vir Biotechnology and GlaxoSmithKline as well as ones made by Regeneron Pharmaceuticals and Eli Lilly.
Regeneron and Roche's antibody cocktail has also received emergency use approval in India, and will be distributed by drugmaker Cipla. The first batch of the cocktail became available in the country earlier this week.
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